Camille Nebeker, EdD, MS Department of Family Medicine & Public Health School of Medicine, UC San
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1 Camille Nebeker, EdD, MS Department of Family Medicine & Public Health School of Medicine, UC San 2018 Chief Medical/Scientific Officers Conference Sharing Patient-Centered Outcomes Data: Building a Better Mousetrap Based on Learnings from the Research Community Washington, DC October 17, 2018
2 Qualcomm Institute at UC San Diego People 350 Faculty 120 Technical & Support Staffs 200 Industry Partners Students Core Areas Culture Energy Environment Health Technology
3 Center for Wireless and Population Health Systems The Design Lab
4 My Work NIH NSF ORI RWJF UC San Diego ACTRI CA-DOR IBM Research Literacy: BRIC is education designed for noviceresearch team members to increase research literacy and awareness of ethical practices. The BRIC programs have received support from the NIH, NSF, ORI and local sources. Tech-Ethics: CORE is a learning ethics community developed to facilitate the sharing of resources and access to digital health research experts to foster ethical and responsible research and innovation. The CORE is supported by the Robert Wood Johnson thecore.ucsd.edu
5 My Work NIH NSF ORI RWJF UC San Diego ACTRI CA-DOR IBM Citizen Science via Participant-Led Research: People and groups motivated to conduct self-study (e.g., QS, DIY), yet they lack the infrastructure needed. We are working with Project Apollo patients to reflect upon and apply ethical principles, design self-studies, analyze data and share what they learn. AI to Support Healthy Aging : We are working with residents of a retirement community to identify barriers to tech adoption and learn whether they want to be involved in co-design of tech to support their aging independently. All of Us Research Program infrastructure development and bioethics research. We conducted qualitative research to learn about informed consent via broad consent and return of information to achieve return of value.
6 Determinants of Health Current estimates indicate genetics explain an important but modest portion (e.g., ~30%) of an individual s variability in health. Health behaviors (e.g., physical inactivity, diet, tobacco use) explain an additional 40% of variance, with the remaining variance attributed to environment factors, social circumstances, and healthcare utilization and delivery. Image courtesy of Dr. Kevin Patrick, Principal Investigator of the Health Data Exploration Project
7 Mobile Imaging MISST Pervasive Sensing Social Media Location Tracking
8 Visual Methods Increasing interest in studying freeliving behavior in the wild prompts increased use of visual methods.
9 Sensing Methods Passive, Pervasive, Ubiquitous With permission of Dr. Todd Coleman, UC San Diego Professor of Electrical & Computer Engineering and CORE Advisor 61
10 Social Media Methods 62
11 New Methods = New Data
12 Commercial Products 64
13 Characteristics of Digital Research We live in an increasingly smart and connected environment and research methods and tools are changing. Now people can monitor or be monitored and/or intervened with 24/7, on the fly and in real time. Research isn t exclusively an academic venture industry, non profits and citizens are in the game. We can now know everything at a granular level using new digital technologies. Promising data anonymity is not realistic. Not all in this emerging digital research ecosystem are regulated and not all are socialized in ethical practices.
14 Key Ethical Legal and Social Areas Ethical Legal/Regulatory Societal Research Literacy Cultural Literacy Data Literacy Bystander Rights Risk / Benefits OHRP FDA Liability Legitimacy Intellectual Property Downstream impact Unknown Unknowns Obligations to share Sociotechnical
15 EMPIRICAL RESEARCH ON RESEARCH ETHICS IRB Content Analysis IRB Focus Groups Participant Survey Participant Digital Divide Participant Terms & Conditions NIH RePORTER Inconsistent Risk Assessment Threats to Participant Privacy Device Comfort Legal Risks Privacy Policy Missing Nature & Scope Bystander Rights IRB Expertise Gaps Consent Gaps Consent Gaps Above Avg. Reading Level MISST research increased 384% between Data Management Interest in Sharing Resources Privacy Bystanders & Participants Social Implications Not Accessible to Youth 35% PA 31% Substance Use 25% Contextual 15.6% disease mgmt
16 Precision Health/Medicine Considerations Capacity Building Informed Consent Bystander Rights Risk Assessment Data Management Team Science Participants as Partners Accessible Education Authentic Engagement Research Literacy Data Literacy Right to Consent Governance Subjective Evidence-based Security Sharing - Return of Information Common Language Involvement of Behavioral and Social Sciences Authentic Engagement Capacity Development Nebeker, C., Harlow, J., Giacinto-Espinoza, R., Linares-Orozco, R., Bloss, C., Weibel, N. (2017) Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives, American Journal of Bioethics: Empirical Bioethics 8:4, , DOI: /
17 We asked: How Might People Shape Ethical Practices? Tool Makers Participants Researchers IRBs make innovative technologies used in health research participate in studies contribute data to advance knowledge conduct health studies using 21st century tools/methods reviews research risks and benefits to make sure participants are protected from harm 69
18
19 Acknowledgements John Harlow Post-Doctoral Scholar Cinnamon Bloss Co-Investigator Nadir Weibel Co-Investigator Araceli López-Arenas Program Manager Sarah Dunseath Research Assistant Ruby Linares-Orozco Research Assistant Janet Johnson CIC Fellow Rasheed Al Kotob CIC Fellow Calvin Gomez CIC Fellow Michelle Takemoto Black CIC Fellow Rebeca Espinoza Giacinto CIC Fellow Todd Coleman David Borasky, Jr. Michelle De Mooy Mary L. Gray Eric Hekler Elisa A. Hurley Paul Kelly Ada Sue Selwitz Donna Spruijt-Metz Katie Shilton Bonnie Spring John Torous John Wilbanks James Fowler Marta Jankowska Jacqueline Kerr Anthony E. Magit
20 Precision Medicine/Health Ecosystem
21 Digital Research Making Headlines
22 What Might be Unknown Unknowns?
23 What Can You Do to Change the Culture? Courtesy of DJ Patil
24 What Can Employees Do?
25 What Can You Read?
26 What Can Organizations Do? Develop a community culture where it is safe for people to question the questionable practices Develop a code of ethics as a community Get to know a tech ethicist Know where to find resources Contribute to shaping ethical practices in the digital age
27 Questions? Contact Info: Camille
28 Sources Sr7GpCA4nirpyo3u68xG1A6NDs/edit#
29 Related Publications
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